CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 894 enrolled
Drug / intervention
Oral Treprostinildrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01027949
NCT01027949Phase 3Completed
CompareCT.gov

An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

United Therapeutics·interventional·Posted Dec 9, 2009·Updated May 10, 2021

In Brief

A Phase 3 clinical trial evaluating Oral Treprostinil for Pulmonary Arterial Hypertension. Completed, enrolled 894 participants across 134 sites in 20 countries.

Detailed Summary

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Austria, Belgium, Canada, China, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2009
Enrollment StartJan 16, 2007
Primary CompletionFeb 12, 2020
TodayJul 2, 2026
Enrollment to primary: 13.1 yearsPosted 16.6 years ago

Interventions

Oral Treprostinildrug

Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.